Rectal AdenocarcinomaDWI_RECT_MRGRTNCT03961776
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
An observational study of Rectal Adenocarcinoma, run by Institut Paoli-Calmettes at 2 sites in 2 countries.
Trial summary
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- MRI-guided radiotherapy by on-board DWI sequences
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jun 2020to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of men and / or women over 18 years of age, with no upper limit age, with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.
Who may be able to join
- Patient over 18 years old.
- Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
- Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
- Signed consent to participation.
- For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
- Affiliation to a social security regimen, or beneficiary of such a regimen.
Who cannot join
- Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
- Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
- Exclusive radiation therapy.
- Other associated neo-adjuvant treatment.
- Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
- Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance <30 ml / min),
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- Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
- Participation in a protocol with concurrent treatment.
- Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
- Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
- Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
University of California Los Angeles (UCLA)
Los Angeles, California, 90095-1406
Percy LEE, MD
Percy LEE
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, 13009
Dominique Genre, MD, 0033491223778, drci.up@ipc.unicancer.fr
Caroline Gouarné, PhD, 0033491223778, drci.up@ipc.unicancer.fr
About this study
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Read the detailed description
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- MRI-guided radiotherapy by on-board DWI sequences
- Keywords
- Diffusion weighted imaging, Radiation therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided radiotherapy by on-board DWI sequencesDevice
The radiotherapy treatment will be delivered on the MRI-guided radiotherapy platform. The on-board DWI sequences will be performed every three fractions in addition to the treatment session and will last approximately 3-4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| non-metastatic rectal adenocarcinoma nRCT indicated | Patients with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated. Receives: Device: MRI-guided radiotherapy by on-board DWI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of Apparent Diffusion Coefficient measured using MRgRT system
Pathological complete response using AJCC criteria
Measured: At surgery (5 to 10 weeks after completion of chemoradiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start8 Jun 2020
- Primary completionMay 2022 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Marguerite TYRAN, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961776
- Sponsor's protocol ID
- DWI_RECT_MRGRT-IPC 2019-002
- Acronym
- DWI_RECT_MRGRT
- Status last verified
- May 2021
- First submitted
- 20 May 2019
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- ClinicalTrials.gov ID
- NCT03961776
- Acronym / sponsor ID
- DWI_RECT_MRGRT / DWI_RECT_MRGRT-IPC 2019-002
- Conditions
- Rectal Adenocarcinoma
- Keywords
- Diffusion weighted imaging, Radiation therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Detailed description
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-metastatic rectal adenocarcinoma nRCT indicated | – | Device: MRI-guided radiotherapy by on-board DWI sequencesPatients with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of men and / or women over 18 years of age, with no upper limit age, with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.
Key inclusion criteria (6 listed)
- Patient over 18 years old.
- Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
- Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
- Signed consent to participation.
- For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
Key exclusion criteria (11 listed)
- Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
- Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
- Exclusive radiation therapy.
- Other associated neo-adjuvant treatment.
- Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-guided radiotherapy by on-board DWI sequencesThe radiotherapy treatment will be delivered on the MRI-guided radiotherapy platform. The on-board DWI sequences will be performed every three fractions in addition to the treatment session and will last approximately 3-4 minutes. | Device | non-metastatic rectal adenocarcinoma nRCT indicated |
Primary outcome
Predictive value of Apparent Diffusion Coefficient measured using MRgRT system
Time frame: At surgery (5 to 10 weeks after completion of chemoradiation)
Pathological complete response using AJCC criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marguerite TYRAN, MD principal investigator
Institut Paoli-Calmettes
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Adenocarcinoma, run by Institut Paoli-Calmettes at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (33491223778, DRCI.UP@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of Apparent Diffusion Coefficient measured using MRgRT system (time frame: At surgery (5 to 10 weeks after completion of chemoradiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.